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475555 tn?1469307939

PI trials for F4 Geno1?

Anybody know if there have been any trials for F4 (and above) geno 1s, or if any are being slated?

I'm still toying with the idea of waiting for PI approval, in spite of now being F3/F4. Maybe it's crazy. But since my hospital can't offer me anything but SOC (less than 30% chance for me), and there aren't any PI trials coming up in my area, I don't really know what to do. If there were some data on whether the PIs can clear F4s, at least I'd have some idea of my chances if I wait. Or maybe I could just rule it out and go with what's available with a clearer mind.

Information is the name of the game.

25 Responses
971268 tn?1253204399
Hi Mike -- glad I didn't depress you over on your other thread... :)  Were you able to speak to anyone about the TMC435 trial? I don't want to keep pushing it on you, but it is a PI with good results so far and it is recruiting in several cities in Argentina.

Maybe someone else will have another good idea for you.
475555 tn?1469307939
I'm so depressed at this point that it's hard to make it worse [grin].

Re TMC435, if you are referring to trial NCT00882908, I looked it over and was put off. There are so many arms, many without the PI (or with partial PI), that I didn't like it. Plus it's only a Phase II trial, and the results of previous trials are not in yet, I don't
t think. Also, Argentina is not listed as a trial site, and I wouldn't go back to the States for this trial.

But maybe you are thinking of a different trial?
476246 tn?1418874514
Hey my friend. You are treatment naive right? Why don't you take the bull by the horns and treat. If you get the PI drug that would be great, if not, you would still treat with SOC, and that's not a bad thing.

Just my 2 cents...
979080 tn?1323437239
I think Mike716 does not want to end up SOC without an adjunct.
If I were naive geno 1 with no other trial ect.. I would want to add at least
Alinia to the mix .
Anything to increase SVR.
971268 tn?1253204399
Hi Mike,

Well, I just took a look and it seems they changed the trial locations and Argentina is no longer there.  However, I can assure you it was there when I first recommended this trial to you.  Buenos Aires was a location, but unfortunately is now gone.... I don't know why they changed it.  IMHO that's a bummer for you, since I think it's a really good trial, and the docs at the excellent hospital where my husband is treating think so, too.

So this brings me to my next point: maybe your standards for what constitutes an acceptable trial are too high?  Obviously now that Buenos Aires is no longer a location for this trial, you can't be on it, but for the sake of discussion let's take a closer look at it.  

First of all, in four arms out of five (80%) the participants get the trial drug.  The two dosages, if you read the results for the Phase IIa trials, which are available, both achieved excellent viral response -- around a 4.5 log drop at week 1 and undetectable viral load in week 4 in around 90% of patients. Those are pretty darn good statistics.

Also, if you read about the PI's being brought to market first -- Telaprevir and Boceprevir -- you'll see that they are often dosed for only 12 weeks with very good results.  My feeling is that in all four arms of this trial where people get the PI there will be good SVR rates.... of course I can't say anything like that for sure now, but in a trial it's almost never for sure. Bottom line is: 80% of people who participate in this trial get access to the PI's at a dosage and for a duration that looks pretty likely, based on the Phase IIa results, to be effective.

Yeah, we all want to be in the Phase III trial of the next greatest thing, but if it's not available and we need to treat sooner rather than later, it seems to me it's worth it to do some research and take a chance. I certainly understand if you're risk-averse, but remember, there's also a risk in doing nothing.

But that's just me! Whatever you do I hope the very best for you. I like the idea of you tangoing for many more years....
475555 tn?1469307939
I calculate my chances with 48-week SOC as around 20%. It just ain't good enough. I don't want to get on the non-response/relapse roller-coaster.
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